An Investigation Exploring Adhesive Materials and Their Ability to Handle Moisture

Healthy Volunteers Clinical Trial

Official title:

An Investigation Exploring Adhesive Materials and Their Ability to Handle Moisture

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02818257
• Other study ID #: CP263
• Status: Completed
• Phase: N/A
• Start date: June 2016
• Est. completion date: October 13, 2018

Study information

• Verified date: January 2019
• Source: Coloplast A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim is to investigate the impact that water absorption properties in adhesives has on adhesion.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: October 13, 2018
• Est. primary completion date: October 13, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Have given written informed consent

• Be at least 18 years of age and have full legal capacity

• Have intact skin on the area used in the investigation

Exclusion Criteria:

• Currently receiving or have within the past 2 month received radio- and/or chemotherapy

• Currently receiving or have within the past month received topical steroid treatment in the abdominal skin area or systemic steroid (tablet/injection) treatment.

• Are pregnant or breastfeeding

• Having dermatological problems in the abdominal area (assessed by investigator)

• Participate in other clinical investigations or have previously participated in this investigation

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Other:
• Strip A
Adhesive strip A
• Strip B
Adhesive strip B
• Strip C
Adhesive strip C

Locations

Country	Name	City	State
Denmark	Coloplast	Humlebæk

Sponsors (1)

Lead Sponsor	Collaborator
Coloplast A/S

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peel force used to removed adhesive	The three strips applied to skin that has received the same treatment (either buffer 1, buffer 2 or dry) are removed at three different time points (max 60 min) and the peel force is measured.; Peel force (90 degree angle from skin) The tensile tester was mounted on a tripod under which the subject was lying. In this way the tensile tester measures the force (Newton), which was needed to remove the adhesive from the skin with a constant speed and with a mean angel of 90°	60 min